Body Fluid Dynamics in Hemodialysis Patients, an Estimation of Dry Weight

NCT02325908 | Terminated

• 1 other identifier: RRI091-97
• Study Type: observational
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to learn how the amount of fluid in the body of a hemodialysis patient affects him or her. Body hydration is the amount of fluid in the human body and known to be related to blood pressure. Too much fluid can lead to high blood pressure which can cause heart problems and eventually lead to death. Bioimpedance Spectroscopy (BIS) is a method that may be used to measure body hydration. This can be applied in the whole body, arm, trunk, calf, and leg. It is a non-invasive and inexpensive method and no known risk. BIS measurements can be used to assess optimal hydration status which is defined as a patient's ideal weight after completing a dialysis treatment. The investigators hypothesize that your target weight may be better estimated by the BIS. The results of this study, in particular the continuous measurement of calf hydration which is associated with the hydration of the whole body, may provide useful information about physiologic ("healthy") body hydration. It may possibly help to improve treatment procedures for patients in the future. The Renal Research Institute plans to enroll 100 chronic hemodialysis patients and 200 healthy controls in this study.

Conditions

Chronic Kidney Disease

Keywords

Hemodialysis; Estimated Dry Weight

Outcome Measures

Primary Outcomes (1)

• Dry weight as determined by segmental bioimpedance in comparison to baseline

  1 month

Secondary Outcomes (2)

• Mean pre dialysis and post dialysis blood pressure in comparison to baseline

  1 month

• Numbers and doses of blood pressure medications prescribed

  1 month

Study Arms (2)

Hemodialysis patients

Dialysis patients will have their estimated dry weight measured with calf segmental bioimpedance. Based on these measurements, their dry weight will be adjusted and the amount of fluid removed during subsequent dialysis treatments will be increased by 200-300mL. The additional fluid removal will occur during 3 consecutive hemodialysis sessions. In addition, these subjects will also use VStim during these treatments. to prevent common intradialytic symptoms by promoting vascular refilling.

Healthy Controls

No Intervention was administered. Both groups had their hydration status measured with segmental bioimpedance The group of healthy subjects was studied in order to obtain a range of values for normal hydration status.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable hemodialysis patients believed to be at all levels of hydration by their treating physician will be chosen. 100 subjects will be chosen to include approximately 50% women in the hemodialysis program. Subjects will be selected from a wide range of ages and body mass indexes

You may qualify if:

• Stable hemodialysis patients believed to be at all levels of hydration by their treating physician should be chosen.

You may not qualify if:

• Myocardial infarction or stroke in the preceding 6 months
• Two episodes of hypotension (systolic BP \< 90 mmHg) during the 3 dialysis procedures preceding entering the treatment phase
• Grade IV CHF by NY classification
• Simultaneous participation in another clinical study except observational trials.
• Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
• Pregnancy.
• Amputation of a limb.
• Pace maker, implantable pump, artificial joint.

Sponsors & Collaborators

• Renal Research Institute: lead

Related Publications (18)

• Spiegel DM, Bashir K, Fisch B. Bioimpedance resistance ratios for the evaluation of dry weight in hemodialysis. Clin Nephrol. 2000 Feb;53(2):108-14.

  PMID: 10711412 RESULT

• Jaeger JQ, Mehta RL. Assessment of dry weight in hemodialysis: an overview. J Am Soc Nephrol. 1999 Feb;10(2):392-403. doi: 10.1681/ASN.V102392.

  PMID: 10215341 RESULT

• Leypoldt JK, Cheung AK. Evaluating volume status in hemodialysis patients. Adv Ren Replace Ther. 1998 Jan;5(1):64-74. doi: 10.1016/s1073-4449(98)70016-0.

  PMID: 9477217 RESULT

• Zhu F, Schneditz D, Wang E, Martin K, Morris AT, Levin NW. Validation of changes in extracellular volume measured during hemodialysis using a segmental bioimpedance technique. ASAIO J. 1998 Sep-Oct;44(5):M541-5. doi: 10.1097/00002480-199809000-00045.

  PMID: 9804490 RESULT

• Piccoli A. Identification of operational clues to dry weight prescription in hemodialysis using bioimpedance vector analysis. The Italian Hemodialysis-Bioelectrical Impedance Analysis (HD-BIA) Study Group. Kidney Int. 1998 Apr;53(4):1036-43. doi: 10.1111/j.1523-1755.1998.00843.x.

  PMID: 9551415 RESULT

• Katzarski K, Charra B, Laurent G, Lopot F, Divino-Filho JC, Nisell J, Bergstrom J. Multifrequency bioimpedance in assessment of dry weight in haemodialysis. Nephrol Dial Transplant. 1996;11 Suppl 2:20-3. doi: 10.1093/ndt/11.supp2.20.

  PMID: 8803989 RESULT

• Zhu F, Schneditz D, Levin NW. Sum of segmental bioimpedance analysis during ultrafiltration and hemodialysis reduces sensitivity to changes in body position. Kidney Int. 1999 Aug;56(2):692-9. doi: 10.1046/j.1523-1755.1999.00588.x.

  PMID: 10432410 RESULT

• Steuer RR, Germain MJ, Leypoldt JK, Cheung AK. Enhanced fluid removal guided by blood volume monitoring during chronic hemodialysis. Artif Organs. 1998 Aug;22(8):627-32. doi: 10.1046/j.1525-1594.1998.06036.x.

  PMID: 9702312 RESULT

• Lopot F, Kotyk P, Blaha J, Forejt J. Use of continuous blood volume monitoring to detect inadequately high dry weight. Int J Artif Organs. 1996 Jul;19(7):411-4.

  PMID: 8841855 RESULT

• Bogaard HJ, de Vries JP, de Vries PM. Assessment of refill and hypovolaemia by continuous surveillance of blood volume and extracellular fluid volume. Nephrol Dial Transplant. 1994;9(9):1283-7.

  PMID: 7816290 RESULT

• Leunissen KM, Kooman JP, van Kuijk W, van der Sande F, Luik AJ, van Hooff JP. Preventing haemodynamic instability in patients at risk for intra-dialytic hypotension. Nephrol Dial Transplant. 1996;11 Suppl 2:11-5. doi: 10.1093/ndt/11.supp2.11.

  PMID: 8803987 RESULT

• Kouw PM, Kooman JP, Cheriex EC, Olthof CG, de Vries PM, Leunissen KM. Assessment of postdialysis dry weight: a comparison of techniques. J Am Soc Nephrol. 1993 Jul;4(1):98-104. doi: 10.1681/ASN.V4198.

  PMID: 8400074 RESULT

• Franz M, Pohanka E, Tribl B, Woloszczuk W, Horl WH. Living on chronic hemodialysis between dryness and fluid overload. Kidney Int Suppl. 1997 Jun;59:S39-42.

  PMID: 9185103 RESULT

• Zhu F, Kuhlmann MK, Sarkar S, Kaitwatcharachai C, Khilnani R, Leonard EF, Greenwood R, Levin NW. Adjustment of dry weight in hemodialysis patients using intradialytic continuous multifrequency bioimpedance of the calf. Int J Artif Organs. 2004 Feb;27(2):104-9. doi: 10.1177/039139880402700205.

  PMID: 15061473 RESULT

• Frankel VH, McLeod KJ. Calf muscle pump stimulation as an adjunct to orthopaedic surgery. Surg Technol Int. 2005;14:297-304.

  PMID: 16525986 RESULT

• Madhavan G, Stewart JM, McLeod KJ. Effect of plantar micromechanical stimulation on cardiovascular responses to immobility. Am J Phys Med Rehabil. 2005 May;84(5):338-45. doi: 10.1097/01.phm.0000159970.81072.8b.

  PMID: 15829780 RESULT

• Madhavan G, Stewart JM, McLeod KJ. Cardiovascular systemic regulation by plantar surface stimulation. Biomed Instrum Technol. 2006 Jan-Feb;40(1):78-84. doi: 10.2345/0899-8205(2006)40[78:CSRBPS]2.0.CO;2.

  PMID: 16544794 RESULT

• Stewart JM, Karman C, Montgomery LD, McLeod KJ. Plantar vibration improves leg fluid flow in perimenopausal women. Am J Physiol Regul Integr Comp Physiol. 2005 Mar;288(3):R623-9. doi: 10.1152/ajpregu.00513.2004. Epub 2004 Oct 7.

  PMID: 15472009 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

During every study day, 1 tube (3.5mL) will be collected before and 1 tube (3.5mL) after HD. This will be done at each study day until the subject reaches optimal hydration status. These samples will be used to assess Na+, K+, Ca++ concentrations and conductivity of the blood. We'll also measure aldosterone monthly.In case of technical issues (which may include device malfunction, transportation of samples, or scheduling of personnel), samples may be frozen temporarily. Samples may also be frozen and kept for future biochemical studies (see "Consent form for future biochemical studies").

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fansan Zhu, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 25, 2014
• Study Start: April 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02